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  • Systematic review of the surgical management of rotator cuff repair with an augmentative patch: a feasibility study protocol.

    22 November 2018

    BACKGROUND: Shoulder pain is a common problem in the general population and is responsible for prolonged periods of disability, loss of productivity, absence from work and inability to carry out household activities. Rotator cuff problems account for up to 70% of shoulder pain problems and are the third most prevalent musculoskeletal disorder after those occurring in the lower back and neck. Rotator cuff surgery has high failure rates (25-50% within 12 months), and as a result, there is a pressing need to improve the outcome of rotator cuff surgery. Patch augmented surgery for rotator cuff repairs has recently been developed and is increasingly being used within the UK National Health Service. Patch augmented surgery could lead to a dramatic improvement in patient and surgical outcomes, but its clinical and cost effectiveness needs rigorous evaluation. The existing evidence on the use of patches may be at risk of bias as currently only a small number of single-centre comparative studies appear to have been carried out. Additionally, it is unclear for which patches a clinical study (comparative and non-comparative) has been conducted. This paper outlines the protocol for a systematic review intended to summarise the best available clinical evidence and will indicate what further research is required. METHODS: Electronic databases (Medline, Embase and Cochrane) will be systematically searched between April 2006 and the present day for relevant publications using a specified search strategy, which can be adapted for the use in multiple electronic databases, and inclusion criteria. Screening of both titles and abstracts will be done by two independent reviewers with any discrepancies resolved by a third independent reviewer. Data extraction will include information regarding the type of participants, type of intervention and outcomes including but not limited to shoulder-specific function and pain scores, patch-related adverse events and type of study. The results will be summarised in a narrative review where qualitative analysis is not possible. DISCUSSION: This review aims to collate the current evidence base regarding the use of patches to augment rotator cuff repair. The results of this review will help to develop, using consensus methods, the design of a definitive randomised trial assessing the clinical and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and is feasible. SYSTEMATIC REVIEW REGISTRATION: CRD42017057908.

  • Trial of exercise to prevent HypeRtension in young adults (TEPHRA) a randomized controlled trial: study protocol.

    16 November 2018

    BACKGROUND: Hypertension prevalence in young adults has increased and is associated with increased incidence of cerebrovascular and cardiovascular events in middle age. However, there is significant debate regards how to effectively manage young adult hypertension with recommendation to target lifestyle intervention. Surprisingly, no trials have investigated whether lifestyle advice developed for blood pressure control in older adults is effective in these younger populations. METHODS/DESIGN: TEPHRA is an open label, parallel arm, randomised controlled trial in young adults with high normal and elevated blood pressure. The study will compare a supervised physical activity intervention consisting of 16 weeks structured exercise, physical activity self-monitoring and motivational coaching with a control group receiving usual care/minimal intervention. Two hundred young adults aged 18-35 years, including a subgroup of preterm born participants will be recruited through open recruitment and direct invitation. Participants will be randomised in a ratio of 1:1 to either the exercise intervention group or control group. Primary outcome will be ambulatory blood pressure monitoring at 16 weeks with measure of sustained effect at 12 months. Study measures include multimodal cardiovascular assessments; peripheral vascular measures, blood sampling, microvascular assessment, echocardiography, objective physical activity monitoring and a subgroup will complete multi-organ magnetic resonance imaging. DISCUSSION: The results of this trial will deliver a novel, randomised control trial that reports the effect of physical activity intervention on blood pressure integrated with detailed cardiovascular phenotyping in young adults. The results will support the development of future research and expand the evidence-based management of blood pressure in young adult populations. TRIAL REGISTRATION: Clinicaltrials.gov registration number NCT02723552 , registered on 30 March, 2016.

  • COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA): statistical analysis plan for a randomised controlled trial.

    27 November 2018

    BACKGROUND: About 15% of patients fail to achieve a satisfactory clinical outcome following knee replacement, which may indicate the existing model of rehabilitation after surgery is possibly not the most efficacious. The COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA) trial evaluates the effects of a new multi-component community-based rehabilitation programme following knee replacement compared with usual care. METHODS/DESIGN: The CORKA trial is a multi-centre, single-blind, two-arm randomised controlled trial. The primary outcome is the Late Life Function and Disability Instrument (LLFDI) overall function score measured at 12 months post-randomisation which will be analysed using a linear mixed effects model. Secondary outcomes are measured at 6 and 12 months post-randomisation and include the LLFDI frequency and limitation total dimension scores, the Oxford Knee Score, the Knee injury and Osteoarthritis Outcome Score quality of life subscale, the Physical Activity Scale for the Elderly, the EuroQol EQ-5D-5L, and several measurements of physical function. Full details of the planned analysis approaches for the primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. This is an update to the CORKA protocol which has already been published in this journal. DISCUSSION: This paper provides details of the planned statistical analyses for this trial and will reduce the risks of outcome reporting bias and data-driven results. TRIAL REGISTRATION: ISRCTN registry, 13517704 . Registered on 12 February 2015. FUNDING/SPONSOR: The trial is funded by the National Institute for Health Research Health Technology Assessment programme under its commissioned research programme (HTA 12/196/08). The trial sponsor is the University of Oxford.

  • Advances in the evaluation of bone health in kidney transplant patients

    6 November 2018

    © 2017 Sociedad Española de Nefrología. Bone disease related to chronic kidney disease and, particularly, to kidney transplant patients is a common cause or morbidity and mortality, especially due to a higher risk of osteoporotic fractures. Despite the fact that this has been known for decades, to date, an appropriate diagnostic strategy has yet to be established. Apart from bone biopsy, which is invasive and scarcely used, no other technique is available to accurately establish the risk of fracture in kidney patients. Techniques applied to the general population, such as bone densitometry, have not been subjected to sufficient external validation and their use is not systematic. This means that the identification of patients at risk of fracture and therefore those who are candidates for preventive strategies is an unmet need.Bone strength, defined as the ability of the bone to resist fracture, is determined by bone mineral density (measured by bone densitometry), trabecular architecture and bone tissue quality. The trabecular bone score estimates bone microarchitecture, and low values have been described as an independent predictor of increased fracture risk. Bone microindentation is a minimally invasive technique that measures resistance of the bone to micro-cracks (microscopic separation of mineralized collagen fibers), and therefore bone tissue biomechanical properties. The superiority over bone densitometry of the correlation between the parameters measured by trabecular bone score and microindentation with the risk of fracture in diverse populations led us to test its feasibility in chronic kidney disease and kidney transplant patients.

  • Prognostic Modelling

    6 August 2015

    Our prognostic modelling team performs external validation of existing predictive models and builds new models with clinical data

  • Research Synthesis

    6 August 2015

  • Methodology Research

    6 August 2015

    We improve the design and analysis of medical research through applied statistics research. We focus on four key areas related to the medical research that we conduct.

  • Reporting and Outcomes Guidelines

    6 August 2015

    We develop reporting and outcomes guidelines, and monitor their uptake and usage

  • EQUATOR Centre UK

    6 August 2015

    The EQUATOR Network is an international initiative set up to help researchers and journals to publish well-reported, reliable, and usable research papers. The UK EQUATOR Centre, based in the CSM in NDORMS, is the head office and flagship centre of the EQUATOR Network.

  • Using Statistics in Primary Medical Research

    6 August 2015

    CSM medical statisticians conduct clinical and nonclinical medical research, getting involved from study design and funding applications to analysis and publication

  • South Central Research Design Service

    3 August 2015

    The RDS provides free advice on research design to researchers in the South Central region who are developing proposals for national, peer-reviewed funding competitions for applied health or social care research

  • Royal Statistical Society - Oxford local group

    4 August 2015

    Academics and non-academics with an interest in statistics are invited to join our annual programme of talks and lectures on statistical topics

  • Ethics Committees

    9 September 2015

    CSM members are consultant statisticians on research ethics committees, ensuring that research respects the dignity, rights, and welfare of its human participants

  • Trial Steering Committees

    9 September 2015

    CSM members serve on trial steering committees, which provide overall supervision of trials.